Provisio Medical: Revolutionizing Vessel Sizing, A Critical Part of Any Cardiovascular Procedure
Provisio Medical looks to establish a new standard in vessel sizing, improving the way that cardiovascular procedures are performed. Provisio’s SLT IVUS™ technology, which can be integrated into the type of catheters physicians are already using, is designed to revolutionize interventional therapy, improving outcomes by giving physicians the exact information that they need, when they need it, while enhancing procedural workflow.
The current predominant guidance method for endovascular therapies is fluoroscopy, a decades-old technology that requires injection of kidney-toxic contrast media and provides low-resolution 2D images of blood vessel lumens, which are very complex 3D structures. While accurate sizing has been shown in numerous studies to improve outcomes, the utilization of endovascular measurement is limited to approximately 5% due to the difficulty of interpretation and the significant amount of additional time and cost to perform the imaging procedure.
Provisio’s SLT IVUS™ technology provides physicians with the precise size and shape of a lumen or body structure without the cost, time and complexity of conventional endovascular imaging. The information provided to the physician in real-time does not need interpretation which eliminates complexity. By overcoming these barriers of conventional endovascular imaging, Provisio looks to unlock the potentially life-saving outcome improvements of endovascular sizing as demonstrated across dozens of studies and tens of thousands of patients.
Provisio Medical is developing a broad offering of endovascular SLT-enabled catheters which are classified as Class II devices and generally FDA cleared through the 510(k) process, often with little to no clinical data required. These products include support catheters, PTCA and PTA balloon catheters, and similar devices. Provisio will explore partnering and development opportunities for Class III devices such as stent systems, catheter-based valve systems, drug-eluting balloon catheters and other advanced therapeutic catheters that could benefit from our integrated SLT technology. Provisio intends to leverage the wealth of existing clinical data that illustrates the critical importance of proper sizing to achieve optimal outcomes.
Provisio Medical is currently developing the SLT IVUS system and over-the-wire support SLT catheters with the expectation of filing for FDA clearance in mid-2022. Rapid-exchange SLT catheters and combination class II catheters will be available thereafter. Additionally, Provisio intends to investigate co-development opportunities of class III SLT-integrated products across a range of procedures with interested parties.